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FDA Approves GSK Antiretroviral Drug Dolutegravir

The FDA on Monday approved GlaxoSmithKline’s antiretroviral dolutegravir, an integrase strand transfer inhibitor “that was developed by ViiV Healthcare Ltd., its joint venture with two other drugmakers,” Bloomberg reports (Edney, 8/12). “The pill is taken daily in combination with others and can be prescribed to patients who have never taken therapy before, as well as those that have,” The Hill’s “RegWatch” blog notes (Hattem, 8/12). The drug, known under the brand name Tivicay, “was tested in adults in four clinical trials in combination with other antiretroviral drugs, and in one trial involving children,” according to Reuters (8/12).